Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)

NCT02679170 | Completed Results

• 3 other identifiers: A8081057IDEALKROSIDEALK
• Study Type: observational
• Target: 692
• Locations: 1 country
• Sites: 32

Brief Summary

Prospective observational study to IDEntify patients with advanced/metastatic NSCLC and ALK and ROS1 translocation and to establish their therapeutic management (IDEALK\&ROS)

Conditions

Non-Small Cell Lung Cancer

Keywords

ALK+, ROS1

Outcome Measures

Primary Outcomes (18)

• Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only

  ECOG quality of life score is a rating of a participant's disease status, daily living activities and quality of life, where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG quality of life scores were reported in this outcome measure.

  At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)

• Number of Participants Classified According to the Origin of Tumor Sample

  Number of participants classified according to the origin of tumor sample (primary tumor or metastasis) were reported in this outcome measure.

  At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis)

• Number of Participants Classified According to Type of Sample Collected for Tumor Analysis

  Number of participants classified according to the type of sample collected (biopsy, cell block or cytology) were reported in this outcome measure.

  At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis)

• Number of Participants Classified According to Histological Subtype of Tumor

  Number of participants classified according to the histological subtype (adenocarcinoma, squamous, large cell, not otherwise specified \[NOS\], other) were reported in this outcome measure.

  At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of diagnosis of ALK and ROS1 metastatic disease)

• Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study

  Tumor Node Metastasis (TNM): based on tumor size, metastasis to nearby lymph nodes (LN), or distant metastasis. Stages were: stage IIIA (T0N2M0, T1N2M0,T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IV (any T any NM1), where T0 = early form of tumor, T1 = less than (\<) 2 centimeter (cm), T2 = 2-5 cm, T3 = greater than (\>) 5 cm, T4 = large sized, N0 = not spread to lymph nodes (LN), N1 = spread to 1 to 3 LN, N2 = spread to 4 to 9 LN, N3 = spread \>10 axillary LN, M0 = no metastasis, M1 = metastasis. The number of participants classified according to stages of tumor (Stage IIIA, IIIB and IV) were reported in this outcome measure.

  At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis of metastatic disease)

• Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study

  Number of participants classified according to molecular alterations (PD-L1+: programmed death-ligand 1 positive, MET+: mesenchymal epithelial transition factor receptor positive, TP53+: tumor protein 53 positive, AKT: serine/threonine-protein kinase) in tumors were reported in this outcome measure.

  At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)

• Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study

  Number of participants classified according to the location of metastases were reported in this outcome measure. One participant may have more than one site of metastases.

  At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)

• Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study

  Number of participants classified according to number of treatments (1 or 2) prior to crizotinib were reported in this outcome measure.

  At baseline (for ALK treatment sub-study: after initial diagnosis of ALK metastatic disease; for ROS1 treatment sub-study: after initial diagnosis of ROS1 metastatic disease)

• Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study

  Number of participants with treatment response as complete response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), partial response (PR): at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), progressive disease (PD): at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were reported in this outcome measure.

  From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)

• Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study

  The number of participants classified as dead or alive were reported in this outcome measure.

  From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)

• Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study

  QLQ-C30: 30 item questionnaire consisted of a global health (GH) score, 5 functional domains, 8 symptom scales and single item about financial difficulties. All items were graded by severity experienced during previous week and used a 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0 - 100. Higher GH and functional domain scores indicated better function and lower scores in symptom scales and single item indicated more severity. Positive changes from baseline indicated improvement and negative changes from baseline indicated worsening for GH and functional domains. Negative changes from baseline indicated improvement and higher levels of functioning and positive changes from baseline indicated worsening for symptom scale and single item. Stable indicated that the symptoms were neither improving nor worsening.

  Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)

• Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study

  QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer \& treatment side effects typical of treatment with chemotherapy and radiotherapy. It comprised of multi-item scale and single-item scale for symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, \& medicine for pain). Response range - 1: Not at all to 4: Very much. The scores were converted to a HRQoL scale ranging from 0 - 100 where, higher scores = greater level of symptoms. Negative changes from baseline indicated improvement and positive changes from baseline indicated worsening. Stable indicated that the symptoms were neither improving nor deteriorating.

  Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)

• Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study

  The percentage of participants with ALK positive translocations were reported in this outcome measure.

  At baseline (after initial diagnosis of lung cancer and until end of recruitment of ALK incidence sub study)

• Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study

  Progression-free survival (PFS) was defined as the period between the first day of treatment and the first day that progressive disease (PD) (at least a 20% increase \[including an absolute increase of at least 5 mm\] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed according to response evaluation criteria in solid tumors (RECIST) criteria, or death. Participants who have not had an event at the time of the analysis of the study data were censored at the date of the last available follow-up.

  From first day of treatment until date of progressive disease, death or censored, whichever was the earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)

• Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study

  ORR: percentage of participants who achieved CR : disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size(\<10 mm short axis), or PR : at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Additionally, the participants with SD : neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. The participants were evaluated in accordance with RECIST criteria.

  From first day of treatment until date of CR, PR or SD (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)

• Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study

  Duration of response (DOR) in participants with PR or CR was defined as the interval from the date the best response was documented to the first date that progressive disease (at least a 20% increase \[including an absolute increase of at least 5 mm\] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed.

  From the date the best response was documented until the date of progressive disease (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)

• Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study

  Overall survival (OS) was defined as the period from the first day of treatment until death or censored up to the last date on which it was known that the participant was alive.

  From first day of treatment until date of death or censored, whichever was earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)

• Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study

  An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. The number of participants with non-SAEs and SAEs were reported in this outcome measure.

  From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)

Study Arms (1)

Routine clinical practice group (NSCLC ALK+, ROS1)

Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+ or ROS1

Drug: Crizotinib

Interventions

Crizotinib DRUG

Treatment with crizotinib following routine clinical practice

Routine clinical practice group (NSCLC ALK+, ROS1)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NSCLC Patients, ALK +translocation confirmed, ROS1+translocation confirmed

You may qualify if:

• For ALK Incidence substudy
• Patients with Advanced or metastatic non-small cell lung cancer
• Patients who will be screened for anaplastic lymphoma kinase (ALK) rearrangement
• Age \> 18 years For ALK treatment substudy (retrospective and prospective)
• Age \> 18 years
• Confirmed anaplastic lymphoma kinase (ALK)-positive tumour
• Patients treated with crizotinib under routine clinical practice
• Patients with a minimum data registered at the medical history
• For the patients that will be recruited prospectively: Patients must have a signed informed consent document.
• For the ROS1 treatment sub-study (retrospective only):
• Age \> 18 years
• Confirmation of NSCLC with ROS1-positive translocation
• Have been eligible to receive treatment with crizotinib according to routine clinical practice since the market launch of the ROS1 indication in Spain on 8 February 2017 until the opening of the site.
• Patients should have a predetermined minimum amount of data recorded in their medical records.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (32)

Hospital Clínico Univ. de Santiago de Compostela

Santiago de Compostela, A Coruña, 15076, Spain

Location

Hospital Virgen de los Lirios

Alcoy, Alicante, 03804, Spain

Location

Complejo Hospitalario de Jerez

Jerez de la Frontera, Cadiz, 11407, Spain

Location

Hospital Marqués de Valdecilla

Santander, Cantabria, 9008, Spain

Location

Hospital General Mancha Centro

Alcázar de San Juan, Ciudad REAL, 13600, Spain

Location

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, LAS Palmas, 35010, Spain

Location

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Cruces

Barakaldo, Vizcaia, 48903, Spain

Location

Hospital Universitario de Albacete

Albacete, 02006, Spain

Location

Hospital Universitario Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital Universitario Puerta del Mar, Cádiz

Cadiz, 11009, Spain

Location

Complejo Hospitalario de Jaen

Jaén, 23007, Spain

Location

Complejo Hospitalario Universitario Insular Materno-Infantil

Las Palmas de Gran Canaria, 35016, Spain

Location

Hospital Universitario de León

León, 24080, Spain

Location

Hospital Universitario San Pedro, Logroño

Logroño, 26006, Spain

Location

Hospital Universitario Lucus Augusti (HULA_ Lugo)

Lugo, 27003, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jimenez Diaz

Madrid, 28040, Spain

Location

H.U. La Paz

Madrid, 28046, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

Hospital Universitario Arrixaca

Murcia, 30120, Spain

Location

Complejo Hospitalario Universitario de Ourense (CHUOU)

Ourense, 32005, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

HU Son Llatzer, Palma de Mallorca / Servicio de Oncología Médica

Palma de Mallorca, 07198, Spain

Location

Hospital Universitario de la Candelaria, Tenerife

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Virgen de La Salud

Toledo, 45004, Spain

Location

Hospital Universitario y Politecnico La Fe

Valencia, 46026, Spain

Location

Hospital Universitario de Vigo- Hospital Álvaro Cunqueiro / Servicio de Oncología Médica

Vigo, 36312, Spain

Location

Related Publications (1)

• Aguado de la Rosa C, Cruz Castellanos P, Lazaro-Quintela M, Domine M, Vazquez Estevez S, Lopez-Vivanco G, Firvida Perez JL, Alonso Romero JL, Ferrera Delgado L, Garcia Giron C, Diz Tain P, Alvarez Alvarez R, Mut Sanchis P, Fernandez Canton I, Manrique Abos I, Martinez Aguillo M, Gomez-Aldaravi Gutierrez L, Ortega Granados AL, Alvarez Cabellos R, Garcia Sebastian A, Garcia Sifuentes LF, Reguart N. Identification of ALK-positive patients with advanced NSCLC and real-world clinical experience with crizotinib in Spain (IDEALK study). Lung Cancer. 2022 Nov;173:83-93. doi: 10.1016/j.lungcan.2022.09.010. Epub 2022 Sep 19.

  PMID: 36162227 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Crizotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 10, 2016
• Study Start: June 29, 2016
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (32)